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Iron Chelator

Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery (START Trial)

Phase 2
Waitlist Available
Research Sponsored by Renibus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 5 post-cardiac surgery

Summary

This trial is testing a treatment made of tin-related and iron substances on patients at risk of kidney damage after heart surgery. The treatment aims to help the body handle surgical stress better, reducing the chance of kidney injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through pre-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through pre-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the Efficacy of RBT-1 in Generating a Preconditioning Response as Measured by a Composite of Biomarkers
Secondary study objectives
Change in Renal Tubular Injury Biomarkers
Number of Subjects With Acute Kidney Injury (AKI)
Number of Subjects With Reduction in Urine Output

Side effects data

From 2023 Phase 2 trial • 152 Patients • NCT04564833
30%
Nausea
26%
Hypotension
24%
Atelectasis
22%
Atrial fibrillation
22%
Photosensitivity reaction
20%
Procedural pain
20%
Pleural effusion
13%
Anemia
13%
Urine output decreased
11%
Constipation
11%
Hypervolemia
11%
Hyperglycemia
11%
Urinary tract infection
9%
Leukocytosis
9%
Incision site pain
7%
Diarrhea
7%
Acute kidney injury
7%
Edema peripheral
7%
Dyspnea
7%
Generalized edema
7%
Pulmonary edema
7%
Subcutaneous emphysema
4%
Cardiomegaly
4%
Edema
4%
Insomnia
4%
Photosensitivity
4%
Thrombocytopenia
4%
Chest pain
2%
Abdominal distention
2%
Acute respiratory failure
2%
Duodenal ulcer hemorrhage
2%
Gastrointestinal hemorrhage
2%
Carbon dioxide increased
2%
Delirium
2%
Hallucination
2%
Sepsis
2%
Breath sounds abnormal
2%
Respiratory failure
2%
Transient global amnesia
2%
Device dislocation
2%
Wound infection
2%
Pneumonia
2%
Blood loss anemia
2%
Cerebral infarction
2%
Ventricular tachycardia
2%
Non-cardiac chest pain
2%
Upper airway obstruction
2%
Pericardial effusion
2%
Ventricular fibrillation
2%
Dizziness
2%
Pneumothorax
2%
Pain
2%
Cardiogenic shock
2%
Atrial flutter
2%
Atrioventricular block complete
2%
Bradycardia
2%
Cardiac failure congestive
100%
80%
60%
40%
20%
0%
Study treatment Arm
High Dose RBT-1
Low Dose RBT-1
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose RBT-1Experimental Treatment1 Intervention
Single IV infusion prior to cardiac surgery
Group II: High Dose RBT-1Experimental Treatment1 Intervention
Single IV infusion prior to cardiac surgery
Group III: PlaceboPlacebo Group1 Intervention
Single IV infusion prior to cardiac surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Dose RBT-1
2021
Completed Phase 2
~160
High Dose RBT-1
2021
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Renibus Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
956 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
96 Patients Enrolled for Acute Kidney Injury
~35 spots leftby Dec 2025
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